Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL SDN BHD C BN2S 14X5/15 SIL SUP; CATHETER, RETENTION TYPE, BALLOON
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

UNOMEDICAL SDN BHD C BN2S 14X5/15 SIL SUP; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Model Number HA14141002
Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
Complainant reported "peel pouch not correctly sealed - leakage.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
C BN2S 14X5/15 SIL SUP
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
UNOMEDICAL SDN BHD
bakar arang industrial estate
sungai petani
kedah, 08000
MY  08000
Manufacturer Contact
jeanette johnson
7900 triad center drive
greensboro, NC 27409
3365424681
MDR Report Key5289550
MDR Text Key33279379
Report Number9611710-2015-40053
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K770256
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 11/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/01/2017
Device Model NumberHA14141002
Device Lot Number405353R001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2012
Is the Reporter a Health Professional? No
Date Manufacturer Received11/06/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-